CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR886.4335]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 886 -- OPHTHALMIC DEVICES

Subpart E - Surgical Devices

Sec. 886.4335 Operating headlamp.

(a) Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]